Clinical trials: Valve Disease, Aortic
Aortic Valve Stenosis
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore…
- Trial name
- ACCESS-TAVI (NCT05503199)
- Testing
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo)., Combination of two ProGlides or ProStyles (Abbott Vascular).
- Where
- Germany
- Volunteers
- 450 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Dedicated Sheath Feasibility Study
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).
- Trial name
- BAV (NCT02617524)
- Testing
- Valve Medical Dedicated Sheath version 00
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Valve Medical
Aortic Valve Stenosis
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial
This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECT (NCT02448927)
- Testing
- balloon aortic valvuloplasty, Transcatheter Aortic Valve Implantation
- Where
- 4 sites in Greece, Israel
- Volunteers
- 170 people
- Sponsor
- National and Kapodistrian University of Athens
CAD - Coronary Artery Disease, CABG
Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery
The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery.
- Conditions
- CAD - Coronary Artery Disease, CABG, Valve Disease, Heart, Aortic Diseases
- Trial name
- NCT07379294
- Testing
- CONVAFoam Hydrofiber Dressing, Standard Pressure Injury Prevention Care
- Volunteers
- 80 people
- Sponsor
- Shih,Wen-Chi
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Patient Quality of Recovery After TAVR With Different Sedation Regimens
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure.
- Trial name
- NCT07556523
- Testing
- Propofol, Dexmedetomidine, Midazolam
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- David Lyubashevsky
Aortic Stenosis
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Trial name
- AMETHYST (NCT06924151)
- Testing
- surgical aortic valve replacement, Transcatheter aortic valve replacement
- Where
- 37 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Osaka University
Aortic Stenosis
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for…
- Trial name
- NCT02628899
- Testing
- Transfemoral TAVR, SAVR
- Where
- 11 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medstar Health Research Institute
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Aortic Stenosis
Effects of Rosuvastatin on Aortic Stenosis Progression
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis.
- Trial name
- ASTRONOMER (NCT00800800)
- Testing
- Rosuvastatin
- Where
- 15 sites in Canada
- Volunteers
- 378 people
- Sponsor
- AstraZeneca
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
An Observational, Prospective Evaluation of the Trifecta™ Valve
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional…
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00727181
- Testing
- Trifecta aortic heart valve
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Trial name
- NCT06775834
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Ascending Aorta Aneurysm, Dilation of the Ascending Aorta
Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
- Trial name
- NCT04372563
- Testing
- aortic prosthetics
- Where
- 2 sites in Russia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Aortic Valve Disease, Ischemia-reperfusion Injury
The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement
A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
- Trial name
- NCT03818126
- Testing
- del Nido cardioplegia, cold blood cardioplegia
- Where
- Poland
- Volunteers
- 150 people
- Sponsor
- Pawel Buszman
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Aortic Valve Stenosis
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification.
- Trial name
- NCT01939678
- Where
- Sweden
- Volunteers
- 3 people
- Sponsor
- Region Örebro County
Aortic Stenosis
Role of Elastin Metabolites in Aortic Remodelling in AS
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age.
- Trial name
- ELASTIC-AS (NCT03883490)
- Testing
- ECG, Blood test and biobanking, Trans-thoracic Echocardiogram
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- University of Leicester
Hypertrophic Cardiomyopathy
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
The purpose of this study is to assess the effectiveness of mavacamten treatment in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in real-world clinical practice
- Trial name
- SOAR-HCM (NCT07361289)
- Testing
- Mavacamten
- Where
- 15 sites in China
- Volunteers
- 500 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
CAN3T - Canadian TAVI Triage Tool
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist.
- Trial name
- CAN3T (NCT06551610)
- Testing
- Triage Tool
- Volunteers
- 5,060 people
- Sponsor
- Sunnybrook Health Sciences Centre
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